SIMpill Medication Dispensing Device in the Treatment of HCV

NCT01691235 | Withdrawn

• 1 other identifier: 12-1293
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Subjects are being asked to participate in this study because they have genotype 1 Hepatitis C Virus (HCV) and will be taking the standard of care drugs pegylated interferon, ribavirin, and telaprevir as part of their routine care. The purpose of this study is to see if the SIMpill automated pill dispensing device can help subjects take their medications at the times the doctor has instructed them to take it. The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. Physicians can download this data and generate a precise account of when you have taken your medication. In addition, if a dose is missed, the SIMpill device can be set to automatically notify you by text message if a dose is overdue. The Simpill device is a new way to keep track of when you take your HCV medications and will also help remind you when you forget to take a dose. In addition, this information will help your doctors understand how taking medication on time effects the success of the therapy.

Conditions

Chronic Hepatitis C Virus

Keywords

SIMpill; HCV; Chronic Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Improved SVR Rates

  To determine if the Simpill devise will improve viral kinetics from week 0 to week 4, leading to improved SVR rates.

  2 years

Secondary Outcomes (1)

• Improved Patient Adherence Rates

  2 years

Study Arms (2)

Arm 1

Subjects in this arm will receive their medication (telaprevir, interferon and ribavirin) dispensed using the Simpill device. The study staff will have access to data from the device during therapy and will be able to give subjects feedback on adherence during the course of therapy. The study team will refill the device as the medication is needed. The device will be configured to remind a subject each time a dose is missed. Subjects in this study arm will receive a text message each time a dose of medication is missed. This message will only go to the telephone number specified by the subject and will not go to members of the study team.

Device: SIMpill device

Arm 2

Subjects in this arm will receive their medication (telaprevir, interferon and ribavirin) as standard of care therapy where the SIMpill device will not be used.

Interventions

SIMpill device DEVICE

The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. This works through a computer chip that is housed inside of the pill dispensing device that is activated each time the pill box is opened. Physicians can download this data and generate a precise account of the patient's adherence to the medication dosing schedule. In addition, if a dose is missed, the SIMpill device can be set to automatically notify the patient by text message if a dose is overdue.

Arm 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from the outpatient/inpatient Liver GI clinic at the University of Chicago Medical Center

You may qualify if:

• Patients age 18 - 70 with genotype 1 HCV
• Compensated liver disease who are independently deemed an appropriate candidate for telaprevir containing HCV treatment regimen

You may not qualify if:

• Prior liver transplantation
• Co-infection with other types of viral hepatitis and HIV

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A blood draw (about 1 tablespoon) if the medication is not working for a subject. This blood draw is another way for the study team to measure adherence to the therapy. This blood draw will be taken only once at the time HCV in the blood return to high levels. This blood draw will measure HCV resistance.

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Aronsohn, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 24, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

US (1)